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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Opiates
510(k) Number K023047
Device Name AMEDICA DRUG SCREEN OPIATES TEST
Applicant
Amedica Biotech, Inc.
28301 Industrial Blvd. Suite K
Hayward,  CA  94545
Applicant Contact Jeff Chen
Correspondent
Amedica Biotech, Inc.
28301 Industrial Blvd. Suite K
Hayward,  CA  94545
Correspondent Contact Jeff Chen
Regulation Number862.3650
Classification Product Code
DJG  
Date Received09/12/2002
Decision Date 11/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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